Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin

Wrinkles Clinical Trial

Official title:

Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603029
• Other study ID #: Belinal 01-2015
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: March 7, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Higher School of Applied Sciences (VIST)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objective of the study is to determine the influence of the cream with Silver fir wood (Abies alba) extract (Belinal) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal part twice a day for 12 weeks. Various face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. To evaluate the photoprotective potential of Belinal the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the cream use at the gluteal area.

Description:

Objective of the study is to determine the influence of the cream with Silver fir wood (Abies alba) extract (Belinal; 2% cream) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal area (split-face and split-gluteal area ) twice a day for 12 weeks. Face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. The photoprotective potential of Belinal will be evaluated with a determination of the minimal erythema dose (MED) at the gluteal area before (the baseline) and after 12 weeks of the cream use. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• Signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin),

• Phototype II and III.

Exclusion Criteria:

• Allergy to ingredients of tested products

• Diagnosed diabetes

• Thyroid disease

• Inflammatory dermatoses

• Regular use of dietary supplements 6 months or less before start of the study,

• Invasive rejuvenation treatments (botox injections, hyaluronic acid fillers, needle rollers, needle mesotherapy, etc.) 6 months or less prior to start of the study,

• Non-invasive rejuvenation treatments (radiofrequency, electrotherapy, ultrasound therapy, no-needle mesotherapy, etc.) 3 months or less prior to start of the study,

• Regular, at least 14 day use of anti-aging cosmetic products containing peptides/ polyphenols/ stem cells extracts/ vitamins in high concentration/ AHAs/ BHAs/ vitamin A or its derivatives) three months or less prior to start of the study,

• Gluteal hyperpigmentation,

• Expected sunbathing (also in solariums) within the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Ageing
• Photoprotection
• Skin Care
• Skin Cream
• Wrinkles

Intervention

Other:
• Placebo cream
Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.
• Belinal cream
Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Higher School of Applied Sciences (VIST)	Abies Labs d.o.o.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of photoprotective function of the skin	Minimal erythema dose (MED) of the skin will be determined. Skin on the gluteal part of the body will be exposed to 10 different doses of UVB light and 24 hours after exposure MED will be determined. Higher MED indicates better photoprotective function of the skin.	up to 12 weeks of the supplementation	No
Primary	Improvement of the dermis structure	Ultrasound (US) images of the dermis will be taken and intensity of the dermis determined. Higher intensity of the dermis US images indicates improvement of the collagen and elastin network.	up to 12 weeks of Belinal cream use	No
Secondary	Reduction of the area of the periorbital facial wrinkles	Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.	6 and 12 weeks of Belinal cream use	No
Secondary	Reduction of the volume of the periorbital facial wrinkles	Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.	6 and 12 weeks of Belinal cream use	No
Secondary	Reduction of trans-epidermal water loss	Trans-epidermal water loss (TEWL) will be measured on the face using open-chamber probe. Lower TEWL indicates better skin barrier function and improved skin condition.	6 and 12 weeks of Belinal cream use	No
Secondary	Improved skin hydration	Skin hydration will be measured on the face.	6 and 12 weeks of Belinal cream use	No
Secondary	Improved skin elasticity	Skin elasticity will be measured on the face.	6 and 12 weeks of Belinal cream use	No
Secondary	An increase of the dermis thickness	Dermis thickness will be measured with ultrasound imaging of the skin.	6 and 12 weeks of Belinal cream use	No